Trials / Recruiting
RecruitingNCT07093970
A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors
A Phase I/II, Open-label, Multi-center, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of MRG006A in Patients With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 343 (estimated)
- Sponsor
- Lepu Biopharma Co., Ltd. · Industry
- Sex
- All
- Age
- 17 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG006A in patients with advanced solid tumors.
Detailed description
This study consists of two parts. Phase I is a dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG006A. Phase II is a dose expansion study to further assess the efficacy, safety, pharmacokinetics and immunogenicityof MRG006A at confirmed RP2D.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRG006A | Administrated intravenously |
Timeline
- Start date
- 2024-07-24
- Primary completion
- 2027-12-01
- Completion
- 2028-12-01
- First posted
- 2025-07-30
- Last updated
- 2026-01-22
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07093970. Inclusion in this directory is not an endorsement.